Feasibility of Screening for Early Late Effects of Contemporary Therapy in High-Risk Neuroblastoma Survivors

NCT06480526 | Recruiting

• 2 other identifiers: LEGACYNCI-2024-05183
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The study participant is being asked to be in a research study called LEGACY, because you were treated for high-risk neuroblastoma (HR-NBL). Primary Objective To determine the feasibility of conducting comprehensive evaluations, leveraging the established SJLIFE (St. Jude Lifetime Cohort Study) study infrastructure, in survivors of HR-NBL (high-risk neuroblastoma) who are greater than 2 years from completion of contemporary therapy and were previously treated at SJCRH (St. Jude Children's Research Hospital). Exploratory Objectives

• To describe the health outcomes of survivors of HR-NBL previously treated at SJCRH with contemporary era therapy who are greater than 2 years from completion of therapy.
• To describe the relationship between patient outcomes and social determinants of health (SDOH) in survivors of HR-NBL previously treated at SJCRH with contemporary era therapy who are greater than 2 years from completion of therapy.

Conditions

High-risk Neuroblastoma

Outcome Measures

Primary Outcomes (3)

• Feasibility will be measured by at least 66% participation rate

  To determine the feasibility of conducting comprehensive evaluations, leveraging the established SJLIFE (St. Jude Lifetime Cohort Study) study infrastructure, in survivors of HR-NBL (high-risk neuroblastoma) who are greater than 2 years from completion of contemporary therapy and were previously treated at SJCRH (St. Jude Children's Research Hospital). To establish the feasibility, we will estimate the participation rate. The study is considered to have an acceptable participation rate if the 95% lower bound of the participation rate exceeds 66%. Participation is defined as completing ≥ 75% of all proposed assessments.

  Up to 24 months after participant enrollment.

• To describe the health outcomes of survivors of HR-NBL previously treated at SJCRH with contemporary era therapy who are greater than 2 years from completion of therapy.

  Participants will go through a comprehensive assessment including the SJLIFE core battery and additional studies in the categories of neurological and autonomic, immunological, quality of life, hematological, renal and metabolic, endocrine, cardiorespiratory, and gastrointestinal (see table below). Their health conditions will be defined by normative data and will be graded using the Revised Common Terminology Criteria for Adverse Events (CTCAE) used by Hudson et al. in SJLIFE studies. The prevalence, cumulative incidence, and latency of selected treatment complications in survivors will be estimated. Resting/minimum/maximum heart rate, nerve velocities (median, deep peroneal, common peroneal, Sural), sweat total/baseline/end offset volumes, complete blood cou

  Health outcomes will be assessed on Days 1, 2, 3, 4, or 5 during the SJLIFE and LEGACY campus visit.

• Socioeconomic status will be measured by self-reported demographic information

  Answers to the household survey, which includes single-item evaluations of self-reported race, ethnicity and primary language, collected per U.S. Health and Human Services guidelines, health literacy utilizing a validated 1-item screen, educational attainment, household materials hardship (HMH), and household income.

  Socioeconomic status, assessed via the household survey, will be assessed on Days 1, 2, 3, 4, or 5 during the LEGACY and SJLIFE campus visit.

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants who meet eligibility criteria and consent to enrollment on the study.

You may qualify if:

• Participants were diagnosed with neuroblastoma at \< 18 years of age and categorized as high-risk at that time, according to INSS26 or INRGSS27 criteria.
• Participants were treated for HR-NBL at SJCRH on NB2012 or as per NB2012.
• Participants are ≥ 2 years from completion of therapy. Participants are 5 years of age or older.
• Participant or legal guardian is able and willing to give informed consent.
• Participants must also complete enrollment on SJLIFE.

You may not qualify if:

• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
• Participants who had relapsed or refractory disease during or following completion of modern era treatment for HR-NBL.
• Participants who are pregnant or breastfeeding.
• Participants who are unable to read and understand English

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study Officials

• Sara Federico, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Federico, MD

CONTACT

888-226-4343; referralinfo@stjude.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 28, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)